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Drug major Lupin today said the US health regulator has raised concerns over compliance norms at its manufacturing plant in Indore that produces oral contraceptives.
In a filing to the BSE, Lupin said its Indore plant was audited by the US Food and Drug Administration in January this year and received six observations under Form 483, without specifying details.
The USFDA issues observations under Form 483 that documents and communicates concerns discovered during inspections of manufacturing plants. Once it is issued, a company has 15 days to respond to the USFDA.
Lupin said its two facilities, the Lupin Bioresearch Centre, Pune (LBC) and the manufacturing facility at Pithampur, near Indore, were audited by the US FDA in November, 2014 and January, 2015, respectively.
“Both the audits were completed successfully with LBC not receiving any observations and the Indore facility receiving six observations (483’s),” the filing said.
Since then, the Indore facility has received one abbreviated new drug application (ANDA) approval and two site—transfer approvals, it added.
The company said it has received approval from the USFDA to market its generic bimatoprost ophthalmic solution in the US market, the filing for which was made from its Indore facility.
The final approval is for its product, a generic version of Allergan Inc’s Lumigan Ophthalmic Solution.
“Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary would commence marketing the product shortly,” the filing said.
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